Trial Title:
Hospital-based Validation of the New ELEVATE Screening Tool in Belgium and Ecuador
NCT ID:
NCT06304610
Condition:
Cervical Cancer
HPV Infection
Conditions: Official terms:
Papillomavirus Infections
Uterine Cervical Neoplasms
Conditions: Keywords:
cervical cancer
screening
self-sampling
HPV
underscreened
new ELEVATE tool
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
all participants receive the same tests
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Questionnaire
Description:
Questionnaire to probe socio-demographic data and information regarding sexual and
reproductive health.
Arm group label:
Sample taking and questionnaire
Intervention type:
Procedure
Intervention name:
HPV self-sample
Description:
Collection of HPV self-sample. The study nurse will explain step by step how the
participant should take the test. The participant will also be given written instructions
and the study nurse will always be around if the participant has any questions. The
participant will be asked to take the self-sample in a private room with toilet. After
collection the sample is handed back to the study nurse, who will then take the samples
to the laboratory for analysis.
Arm group label:
Sample taking and questionnaire
Intervention type:
Procedure
Intervention name:
Endocervical sample
Description:
Endocervical sample taken by the gynaecologist. This procedure can be somewhat
uncomfortable but not painful. The participant may always ask questions if she has any
doubts or questions. The gynaecologist will perform the standard colposcopy examination
after collection (for which the woman sits in the colposcopy waiting room)
Arm group label:
Sample taking and questionnaire
Summary:
ELEVATE is a six-year project, conducted by an international research alliance led by
Ghent University, aiming to develop a new test and approach for cervical cancer screening
in hard-to-reach populations.
In this final stage of the project, a hospital-based validation study is deployed in
Belgium and Ecuador to clinically validate the new ELEVATE screening test based on
self-samples and endocervical samples. The simultaneous detection of HPV DNA and the
proteomic markers allows for the detection of those cervical HPV infections associated
with progression towards cervical cancer.
At each study site, 100 women between 30-65 years old, with a recent abnormal pap smear
result will be recruited in the colposcopy waiting room. After registration and signing
the informed consent form, each woman will be asked to fill out a short self-administered
questionnaire for socio-demographic information. Each woman will provide a self-sample as
well as an endocervical sample before the colposcopy examination. Both samples of all 200
women (i.e. participants from Belgium and Ecuador) will be tested with the new ELEVATE
screening test, using 400 ELEVATE cartridges, as well as with standard tests.
Besides analyzing all samples on the new ELEVATE screening test, the following standard
tests will also be performed on all samples (at Ghent University - including the shipped
samples of Ecuador):
- AnyplexTM II HPV HR Detection (Segeene Inc., Korea): approved comparison test
- ELISA protein detection: only available comparison test
In order to generate HPV DNA results locally, that can be communicated to the
participants in short time (versus waiting for AnyplexTM II HPV HR Detection test results
after shipment to Belgium), in Ecuador the following additional standard test will be
performed on the100 endocervical samples (before shipment to Belgium):
• HPV DNA Mole Bioscience test
Concordance between the test results of the ELEVATE screening test and standard lab tests
on both type of samples will be defined, for HPV DNA as well as protein detection.
Additionally, the sensitivity and specificity of the HPV DNA test and the protein test of
the ELEVATE screening test will be defined, according to clinically relevant outcomes.
Detailed description:
ELEVATE is a six-year project, conducted by an international research alliance led by
Ghent University, aiming to develop a new test and approach for cervical cancer screening
in hard-to-reach populations.
In this final stage of the project, a hospital-based validation study is deployed in
Belgium and Ecuador to clinically validate the new ELEVATE screening test based on
self-samples and endocervical samples. This point-of-care test is a portable,
battery-powered device compatible with self-sampling and comprises a Human Papillomavirus
(HPV) DNA test as well as a proteomic biomarkers detection sensor, aiming for high
sensitivity and specificity. The test can be offered in a broad range of settings and
results are available in less than 24 hours, eliminating the need for sample storage and
lab infrastructure. The simultaneous detection of HPV DNA and the proteomic markers
allows for the detection of those cervical HPV infections associated with progression
towards cervical cancer.
At each study site, 100 women between 30-65 years old, with a recent abnormal pap smear
result will be recruited in the colposcopy waiting room. After registration and signing
the informed consent form, each woman will be asked to fill out a short self-administered
questionnaire for socio-demographic information. Each woman will provide a self-sample as
well as an endocervical sample before the colposcopy examination. The self-sample will be
taken by using the Evalyn brush (Rovers - CE-approved device), while the endocervical
sample will be taken by the gynaecologist with a standard endocervical brush used in the
hospital. Both sampling measures are considered non-invasive. The ELEVATE screening tool
is composed out of a device and cartridges. The ELEVATE cartridge is a microfluidic
cartridge, consisting of the 2 sensor types (genomic and proteomic), onto which cervical
fluid will be brought drop by drop. This cartridge will then be introduced into the
ELEVATE screening device, after which via electrochemical signals the HPV DNA and protein
result will become clear. The new ELEVATE screening test (or tool) is an HPV DNA
detection and protein detection test under development; results based on the new test
will not be shared with the patient or health care provider. Results of the tool will be
compared with standard laboratory tests. Only the result of the standard laboratory tests
will be fed back to the patient if requested by the patient (as also mentioned in the
ICF).
The following tests will be performed at UZ Gent:
- new ELEVATE screening test (HPV DNA detection and protein detection) on self-sample
and endocervical samples from women from Belgium (100 women, 200 samples)
- Standard lab test HPV DNA Detection: AnyplexTM II HPV HR Detection (Segeene Inc.,
Korea): approved comparison test; on all samples, including samples sent to Belgium
from the women from Ecuador (200 women, 400 samples)
- Standard lab test protein detection: ELISA protein detection: only available
comparison test; on all samples, inlcuding samples sent to Belgium from the women
from Ecuador (200 women, 400 samples)
In order to generate HPV DNA results locally, that can be communicated to the
participants in short time (versus waiting for AnyplexTM II HPV HR Detection test results
after shipment to Belgium), in Ecuador the following additional standard test will be
performed on the100 endocervical samples (before shipment to Belgium):
- HPV DNA Mole Bioscience test
- new ELEVATE screening test (HPV DNA detection and protein detection) on self-test
and endocervical sample from women from Ecuador (100 women, 200 samples)
Concordance between the test results of the ELEVATE screening test and standard lab tests
on both type of samples will be defined, for HPV DNA as well as protein detection.
Additionally, the sensitivity and specificity of the HPV DNA test and the protein test of
the ELEVATE screening test will be defined, according to clinically relevant outcomes.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- have a previous abnormal pap smear/recent diagnosis of cervical dysplasia (<4
months) and therefore have a colposcopy appointment, or
- a positive HPV test (<4 months) and therefore have a colposcopy appointment, and
- able to understand the study materials (questionnaire) and informed consent form
Exclusion Criteria:
- women with heavy bleeding at consultation
- women with known pregnancy at consultation
- women who are undergoing or have completed chemotherapy in the six months prior to
the enrollment, or received LEEP, cryotherapy or another treatment in the six months
prior to enrollment
- women who do not consent
Gender:
Female
Minimum age:
30 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Ghent University Hospital
Address:
City:
Ghent
Zip:
9000
Country:
Belgium
Contact:
Last name:
Steven Weyers, MD,PhD,Prof
Phone:
09 332 37 83
Email:
steven.weyers@uzgent.be
Contact backup:
Last name:
Philippe Tummers, MD,PhD,Prof
Phone:
09 332 37 83
Email:
philippe.tummers@uzgent.be
Investigator:
Last name:
Philippe Tummers, MD,PhD,Prof
Email:
Principal Investigator
Investigator:
Last name:
Heleen Vermandere, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Marie Hendrickx, MSC
Email:
Sub-Investigator
Facility:
Name:
SOLCA University Hospital
Address:
City:
Cuenca
Country:
Ecuador
Contact:
Last name:
Bernardo José Vega Crespo
Phone:
0998276441
Email:
bernardo.vegac@ucuenca.edu.ec
Investigator:
Last name:
Bernardo José Vega Crespo
Email:
Principal Investigator
Investigator:
Last name:
Dayanara Delgado
Email:
Sub-Investigator
Investigator:
Last name:
Vivian Alejandra Neira Molina
Email:
Sub-Investigator
Start date:
September 1, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
University Hospital, Ghent
Agency class:
Other
Collaborator:
Agency:
Horizon 2020 - European Commission
Agency class:
Other
Collaborator:
Agency:
Universidad de Cuenca
Agency class:
Other
Source:
University Hospital, Ghent
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06304610
